FDA UDI In Commercial Distribution 🇺🇸 United States

MDU5 PLUS

DI: 08714729982852 · Model: H749MDU5PLUSFH0 · BOSTON SCIENTIFIC CORPORATION
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
MDU5 PLUS
Primary DI
08714729982852
Version / Model
H749MDU5PLUSFH0
Catalog Number
H749MDU5PLUSFH0
Company Name
BOSTON SCIENTIFIC CORPORATION
Labeler DUNS
021717889
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-11-29
Public Version
1
Public Version Date
2021-12-07
Public Version Status
New
Public Device Record Key
c9527157-9c74-42d9-88a9-e094896186d1

Device Description

Motordrive Unit

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IYO System, imaging, pulsed echo, ultrasonic
ITX Transducer, ultrasonic, diagnostic
DQK Computer, diagnostic, programmable
DSK COMPUTER, BLOOD-PRESSURE

GMDN Terms

Code Name
40763 Cardiovascular ultrasound imaging system

Identifiers

Type ID
Primary 08714729982852